A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

NCT07155187 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: M25-7132025-521124-29
• Study Type: interventional
• Target: 430
• Locations: 12 countries
• Sites: 46

Brief Summary

Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to assess adverse events and change in disease activity of telisotuzumab adizutecan compared to standard of care (SOC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. This study will be divided into two stages, in the first stage (phase 2) participants will receive 1 of 2 doses of telisotuzumab adizutecan. In the second stage (phase 3) participants will receive the recommended phase 3 dose (RP3D) of telisotuzumab adizutecan, from the previous stage, or SOC. Approximately 430 adult participants with NSCLC will be enrolled in the study in 200 sites around the world. In phase 2, participants will receive 1 of 2 intravenous (IV) doses of telisotuzumab adizutecan. In phase 3, participants will receive the IV RP3D of telisotuzumab adizutecan, or SOC. The study will run for a duration of approximately 69 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer; Telisotuzumab Adizutecan; ABBV-400, Standard of Care; Cancer; AndroMETa-Lung-713

Outcome Measures

Primary Outcomes (2)

• Phase 2: Objective Response (OR) Assessed by Blinded Independent Central Review (BICR)

  OR is defined as participants achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) per BICR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  Up to Approximately 69 Months

• Phase 3: Progression-Free Survival (PFS) as assessed by BICR

  PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by BICR or death from any cause, whichever occurs earlier.

  Up to Approximately 69 Months

Secondary Outcomes (8)

• Phase 2 and 3: Overall Survival (OS) as assessed by BICR

  Up to Approximately 69 Months

• Phase 2: PFS as assessed by BICR

  Up to Approximately 69 Months

• Phase 2 and 3: Duration of Response (DoR) as Assessed by the BICR per RECIST v1.1

  Up to Approximately 69 Months

• Phase 2 and 3: Disease Control (DC) as Assessed by the BICR per RECIST v1.1

  Up to Approximately 69 Months

• Phase 3: OR Assessed by BICR

  Up to Approximately 69 Months

Study Arms (4)

Phase 2: Telisotuzumab Adizutecan Dose A

EXPERIMENTAL

Participants will receive telisotuzumab adizutecan dose A, as part of the approximately 69 month study duration.

Drug: Telisotuzumab Adizutecan

Phase 2: Telisotuzumab Adizutecan Dose B

EXPERIMENTAL

Participants will receive telisotuzumab adizutecan dose B, as part of the approximately 69 month study duration.

Drug: Telisotuzumab Adizutecan

Phase 3: Telisotuzumab Adizutecan Recommended Phase 3 Dose

EXPERIMENTAL

Participants will receive telisotuzumab adizutecan at the recommended phase 3 dose, as part of the approximately 69 month study duration.

Drug: Telisotuzumab Adizutecan

Phase 3: Stand of Care (SOC)

EXPERIMENTAL

Participants will receive investigator's choice of SOC, as part of the approximately 69 month study duration.

Drug: Standard of Care

Interventions

Standard of Care DRUG

Standard of Care

Phase 3: Stand of Care (SOC)

Telisotuzumab Adizutecan DRUG

Intravenous (IV) Infusion

Phase 2: Telisotuzumab Adizutecan Dose A; Phase 2: Telisotuzumab Adizutecan Dose B; Phase 3: Telisotuzumab Adizutecan Recommended Phase 3 Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with documented EGFR Exon 19 deletion or Exon21 L858R mutation.
• Provide archived or recently obtained tumor tissue during Screening.
• Received one prior third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy in the adjuvant, locally advanced, or metastatic setting, either as monotherapy or in combination with other agents, and experienced documented radiographic disease progression on or after therapy for the most recent regimen administered prior to study entry.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
• At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated.
• Central nervous system (CNS) metastasis, these should be clinically asymptomatic or stable after definitive treatment.
• Current, historical, or suspected interstitial lung disease (ILD)/pneumonitis that required steroids should be excluded.
• If the prior third-generation EGFR TKI was administered in the adjuvant setting, progression must have occurred while on treatment.

You may not qualify if:

• Tumor(s) have adenosquamous or squamous histology or sarcomatoid features.
• Received more than 1 line of systemic therapy in the locally advanced or metastatic setting.
• Have any clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (53)

Highlands Oncology Group - Springdale /ID# 277132

Springdale, Arkansas, 72762, United States

RECRUITING

Cancer Care Centers of Brevard- Rockledge /ID# 277853

Rockledge, Florida, 32955, United States

RECRUITING

HealthPartners Cancer Research Center /ID# 277339

Saint Louis Park, Minnesota, 55426, United States

RECRUITING

Nho - Revive Research Institute /ID# 277569

Lincoln, Nebraska, 68506, United States

RECRUITING

Astera Cancer Care /ID# 277570

East Brunswick, New Jersey, 08816-4096, United States

RECRUITING

Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 277891

Knoxville, Tennessee, 37909, United States

RECRUITING

SCRI Oncology Partners /ID# 276959

Nashville, Tennessee, 37203, United States

RECRUITING

Northwest Cancer Specialists - Vancouver /ID# 277855

Vancouver, Washington, 98684, United States

RECRUITING

Canberra Hospital /ID# 277166

Garran, Australian Capital Territory, 2605, Australia

RECRUITING

St George Hospital /ID# 277168

Kogarah, New South Wales, 2217, Australia

RECRUITING

Mater Hospital Brisbane /ID# 276985

South Brisbane, Queensland, 4101, Australia

RECRUITING

Icon Cancer Centre Hobart /ID# 277549

Hobart, Tasmania, 7000, Australia

RECRUITING

St Vincent's Hospital Melbourne /ID# 277002

Fitzroy, Victoria, 03065, Australia

RECRUITING

Sunshine Hospital /ID# 276894

St Albans, Victoria, 3021, Australia

RECRUITING

One Clinical Research - Nedlands /ID# 277598

Nedlands, Western Australia, 6009, Australia

RECRUITING

Klinik Floridsdorf /ID# 276679

Vienna, Vienna, 1210, Austria

RECRUITING

Jessa Ziekenhuis - Campus Virga Jesse /ID# 277202

Hasselt, Limburg, 3500, Belgium

RECRUITING

Universitair Ziekenhuis Leuven /ID# 276874

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Guangdong Provincial People'S Hospital /ID# 277631

Guangzhou, Guangdong, 510080, China

RECRUITING

Universitaetsklinikum Heidelberg /ID# 277275

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Universitaetsklinikum Wuerzburg /ID# 277213

Würzburg, Bavaria, 97080, Germany

RECRUITING

Universitaetsklinikum Giessen und Marburg GmbH /ID# 276873

Marburg, Hesse, 35043, Germany

RECRUITING

Universitaetsklinikum Koeln /ID# 276862

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Universitätsklinikum Jena /ID# 277281

Jena, Thuringia, 07747, Germany

RECRUITING

Meir Medical Center /ID# 277289

Kfar Saba, Central District, 4428164, Israel

RECRUITING

Rabin Medical Center /ID# 276748

Petah Tikva, Central District, 4941492, Israel

RECRUITING

Yitzhak Shamir Medical Center /ID# 276750

Ẕerifin, Central District, 7030000, Israel

RECRUITING

The Chaim Sheba Medical Center /ID# 276745

Ramat Gan, Tel Aviv, 5265601, Israel

RECRUITING

Rambam Health Care Campus- Haifa /ID# 276746

Haifa, 3525408, Israel

RECRUITING

Ospedale Isola Tiberina - Gemelli Isola /ID# 277117

Rome, Roma, 00186, Italy

RECRUITING

Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 277119

Candiolo, Torino, 10060, Italy

RECRUITING

Hokkaido University Hospital /ID# 277240

Sapporo, Hokkaido, 060-8648, Japan

RECRUITING

Kitasato University Hospital /ID# 277241

Sagamihara-shi, Kanagawa, 252-0375, Japan

RECRUITING

National Cancer Center Hospital /ID# 277093

Chuo-Ku, Tokyo, 104-0045, Japan

RECRUITING

Wakayama Medical University Hospital /ID# 277238

Wakayama, Wakayama, 641-8510, Japan

RECRUITING

Unidade Local de Saude do Alto Ave, EPE /ID# 277249

Guimarães, Braga District, 4835-044, Portugal

RECRUITING

Unidade Local de Saude de Loures-Odivelas, EPE /ID# 277223

Loures, Lisbon District, 2674-514, Portugal

RECRUITING

Unidade Local de Saude de Matosinhos, EPE /ID# 277228

Senhora da Hora, Porto District, 4464-513, Portugal

RECRUITING

Unidade Local de Saude de Braga, EPE /ID# 277217

Braga, 4710-243, Portugal

RECRUITING

Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 277216

Porto, 4099-003, Portugal

RECRUITING

National Cancer Center /ID# 277353

Goyang-si, Gyeonggido, 10408, South Korea

RECRUITING

Chungbuk National University Hospital /ID# 277372

Cheongju-si, North Chungcheong, 28644, South Korea

RECRUITING

Seoul National University Hospital /ID# 277373

Seoul, Seoul Teugbyeolsi, 03080, South Korea

RECRUITING

Asan Medical Center /ID# 277371

Seoul, Seoul Teugbyeolsi, 05505, South Korea

RECRUITING

Samsung Medical Center /ID# 277600

Seoul, Seoul Teugbyeolsi, 06351, South Korea

RECRUITING

Hospital Universitario Virgen de la Victoria /ID# 277159

Málaga, 29010, Spain

RECRUITING

Hospital Clinico Universitario de Valencia /ID# 277147

Valencia, 46010, Spain

RECRUITING

Hospital Clinico Universitario Lozano Blesa /ID# 277154

Zaragoza, 50009, Spain

RECRUITING

Changhua Christian Hospital /ID# 277145

Changhua, 500, Taiwan

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 277138

Kaohsiung City, 807, Taiwan

RECRUITING

Taichung Veterans General Hospital /ID# 277142

Taichung, 407, Taiwan

RECRUITING

Mackay Memorial Hospital /ID# 277146

Taipei, 104, Taiwan

RECRUITING

Taipei Veterans General Hospital /ID# 277141

Taipei, 112, Taiwan

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 4, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

IL (5); DE (5); IT (2); AU (1); JP (4); BE (2); PT (5); US (8); CN (1); KR (5); ES (3); TW (5)